NCT03483064

Brief Summary

In our daily clinical practice, one of the most frequent reasons for consultation physiotherapists is low back pain. Regardless of the origin of the problem, the approach from physiotherapy contemplates the reduction of pain through different procedures, among which all those included in electrotherapy stand out, as commented by McKenzie et al. The use of electric currents for therapeutic purposes is widespread and studied in the field of physiotherapy. However, the use of medium frequency currents, and more specifically interferential currents, provides participants with a series of important advantages, both for the patient and for the therapist.The study of low back pain in relation to treatment with interferential currents has a series of obstacles, among which the quantification of such pain and the establishment of the different parameters of the therapeutic procedure stand out. The first problem the investigators face are to objectify something that, in itself, is completely subjective: pain. In addition, pain measurement is our only guide to follow the evolution of the patient who suffers it. Another important problem, as discussed by Ward and Lucas-Toumbourou, has to do with the controversy between the different studies related to the treatment of low back pain with interferential currents. For all the above, the approach to low back pain is complex and affects the social, labor and economic scale of the individual and society. Low back pain is the main cause of public spending for welfare and work concepts. It suffers at some point in life up to 80% of the general population and each year generates a cost equivalent to approximately between 1.7 and 2.1% of its gross domestic product in a European countries. There is a lack of valid scientific studies on some aspects of the clinical management of low back pain and the usual clinical practice does not seem to be based strictly on the results of the researches carried out. The available data suggest that there are abuses of procedures whose benefits and risks are uncertain, while others that have proven to be more effective, safe, effective and / or efficient are underutilized. For this reason, clinical practice guidelines for non-specific low back pain have been developed in several countries in recent years. Since the first clinical practice guidelines developed in America and the United Kingdom (Quebec Task Force in 1987. In 1994, more than 30 guides who claim to be based on scientific evidence have been developed. Electroanalgesia is a set of procedures consisting of the application of an electric current through electrodes placed on the skin of the patient in order to stimulate myelinated nerve fibers, fast driving. This activation triggers, at the central level, the implementation of descending analgesic systems of an inhibitory nature on nociceptive transmission, transported by small-caliber unmyelinated fibers. In this way, a reduction in pain is obtained. In other words, it is a question of carrying out a "differential" sensory stimulation, transcutaneously, of the tactile proprioceptive fibers, with a high speed of conduction, with the minimum response of the nociceptive fibers, of slow conduction, and of the efferent motor fibers. The application of medium frequency interferential currents (4,000 Hz), in addition to reducing the pain caused by the stimulation of thick nerve fibers, produces the normalization of the neurovegetative balance. According to De Domenico, this means a cushioning of the orthosympathetic system, which is reflected in muscle relaxation and improved circulation, which also helps to reduce pain. But the clinical impact of interferential currents on non-specific chronic low back pain remains poorly studied. Thus, clinical trials show some controversy and support its efficacy in combination with other treatments. A systematic review found that the interferential current demonstrates advantages over placebo and without treatment when associated with exercises and massages. In contrast, the European clinical practice guideline for the treatment of chronic low back pain concluded that there was no evidence of its effectiveness compared to sham intervention or placebo. However, recent studies of a randomized clinical trial with interferential currents on patients with nonspecific chronic low back pain report very favorable results in terms of the reduction of perceived pain and functional disability.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

May 7, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2018

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2018

Completed
Last Updated

March 9, 2021

Status Verified

March 1, 2021

Enrollment Period

Same day

First QC Date

March 10, 2018

Last Update Submit

March 5, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Hear rate variability

    NN interval series, measured by sympathetic-parasympathetic balance

    1 day

Study Arms (2)

Control group

NO INTERVENTION

Subjects without low back pain to whom the electric current is put but it is not activated.

Healthy group

EXPERIMENTAL

Subjects without low back pain to whom the electric current is put but it is activated.

Other: Interferential current

Interventions

interferential currents of 4,000 Hz carrier frequency, 100 Hz of AMF, for 20 minutes and with an amplitude up to the motor threshold

Healthy group

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • subjects without low back pain
  • Not being doing another type of physical therapy.

You may not qualify if:

  • Presence of neurological, musculoskeletal or sensory disorder.
  • Infectious, febrile or hypotensive processes.
  • Appreciation to the application of electrotherapy, measured through the EAPP scale

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Blanca de La Cruz Torres

Seville, 41010, Spain

Location

Related Publications (1)

  • De-la-Cruz-Torres B, Martinez-Jimenez E, Navarro-Flores E, Palomo-Lopez P, Abuin-Porras V, Diaz-Meco-Conde R, Lopez-Lopez D, Romero-Morales C. Heart Rate Variability Monitoring during Interferential Current Application in the Lower Back Area: A Cross-Sectional Study. Int J Environ Res Public Health. 2021 Mar 25;18(7):3394. doi: 10.3390/ijerph18073394.

MeSH Terms

Interventions

Electric Stimulation Therapy

Intervention Hierarchy (Ancestors)

TherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

March 10, 2018

First Posted

March 29, 2018

Study Start

May 7, 2018

Primary Completion

May 7, 2018

Study Completion

May 30, 2018

Last Updated

March 9, 2021

Record last verified: 2021-03

Locations